1. Field of the Invention
The object of the invention is a multifunctional, electrophysiological diagnostic catheter used for treatments in electrocardiology consisting of stabilization balloon, especially for stabilization of a catheter in a coronary sinus.
2. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 37 CFR 1.98.
Rapid diagnosis and fast treatment of potentially dangerous arrhythmia allows for significant reduction of patients' morbidity for patients suffering from cardiac arrhythmia, which leads in its most serious form to sudden cardiac death. One of diagnostic method used for cardiac arrhythmia diagnosis is invasive electrophysiological study (EPS), using diagnostic catheters. Reliable identification of cardiac arrhythmia substrate and continuous, precise monitoring of rhythm and catheter electrodes localized intracardiacly are essential.
Catheters equipped with balloons are known from the state of the art. In application, U.S. Pat. No. 3,995,623 shows that there is the catheter described with a flow balloon on its distal end passing through right vestibule, right ventricle, and to the pulmonary artery. Clearance in tubule of catheter is open on the distal end in order to monitor blood pressure in the pulmonary artery or branch, or to obtain blood sample. A thermistor closer to the balloon enables measurement of blood temperature in this region, thus enabling identification of cardiac output using termodilution technique. A second tubule comprises a gap, which is characteristically located in junction region of vena cava and right vestibule, in order to monitor pressure, infusion of liquid media and blood sampling. Besides these two mentioned channels, a third stream is used as a channel for pumping the balloon, and a fourth stream, which comprises thermistor wires, is for distal and proximal electrodes.
Patent No. JP2893833 discloses an endoscopic electrode comprising balloon, which is installed on the front end of tube made of synthetic resin, surrounding a rim of a front pipe and ending in a way to avoid gap closure. Part of the front end connecting with one tube clearance and recess are made by external surface of tube, and the balloon can be communicated with one tube clearance delivering lateral gap to the tube interior or through excision of front tube part. An optical fiber is located in the clearance, and distance between fiber and inner surface of lumen is used as a passage for balloon expansion liquid. The balloon acts as a stabilizer, because even if saline is not used to fill balloon, the catheter position is not changed, and observation or diagnostics can be performed.
US2008097297 is an application describing a medical product, which is able to penetrate blood vessels comprising at least one non-expandable piercing element fitted and configured for specific local activity in vivo e.g. diagnosis, sampling, energy therapy and drug administration. This device additionally comprises at least one inflatable balloon used for local positioning, which is configured for safe placement of device around target tissue of human vessels or internal organs.
EA009756 B1 is an application disclosing a catheter comprising three elastic channels, wherein, first, an internal one delivers fluid for balloon filling, an external is used as a support of balloon localization, and a lateral channel is for lymph sampling. Annular-shaped elastic balloons are equipped with threads for catheter installation in clearance of a venous angle, where an elliptically-shaped elastic balloon is equipped with a trigger plate for a contact with lymph outlet. In case of lymph sampling, placement of the catheter in an operating position in the venous angle depression is required, obtaining growth in volume through increasing elastic balloon volume by injection of saline inside.
Also other solutions are known, which mention a possibility of blood flow blockade e.g. EP0363156, which is an application referring to an apparatus for volumetric blood measurement in vessel with walls characterized in that an elastic catheter is adapted for placement in a vessel and comprises ultrasound sensors. This apparatus is equipped with a device for pressure measurement in right atrium, pressure in pulmonary artery and wedge pressure. Volumetric flow is determined using termodilution.
WO9806450 is an application disclosing a catheter-type device for hemorrhage control during closed surgery. In the end of catheter, there is an inter alia balloon adapted for movement with an elastic catheter along a blood vessel, wherein a pump-enabling channel is located, which makes it possible for fast balloon inflating (filling) and emptying. When a precise balloon location in a surrounding of a blood vessel is confirmed, the balloon is located in the flow in order to close blood flow and prevent hemorrhage in a designated region of surgical intervention. Magnetic material is attached to the aforementioned balloon for magnetic coupling and balloon positioning by manipulation using a magnet located outside of the blood vessel. The catheter can be equipped with a channel adapted for blood sampling and drug delivery.
In the state of art, there are catheters known by which it is possible to take a blood sample.
U.S. Pat. No. 5,607,389A relates to a medical device comprising the probe, cover for the probe, and microdevice for placement, e.g. biopsy sampler for tissue sampling as a needle or sharp end in order to facilitate the sampler reaching out to proper tissue or the sampler having a shape similar to a harpoon or jaws. Further embodiments include a knife sampler and electromagnetic transmitter for selective sample collection and electromagnetic ablative heating.
EP1145731 discloses a multilumenal, multipurpose catheter set comprising multiple axis channels, wherein at least one channel supports other functionality than material delivery and material removal, which left after its delivery. The catheter can comprise at least two individual channels parallel to a middle catheter cylinder. Two channels are used for sampling of fluids from that body part, where the catheter is placed.
Solutions known from the state of the art do not allow for universal connection of all diagnostic functions (measurement of heart potentials, localization and navigation without fluoroscopy, selective blood sampling from suitable vessel or heart cavity localized using catheter ending, possibility of selective delivery of substance or contrast localized using catheter ending and catheter stabilization and blood flow blocking in blood vessel using balloon).
In any of the described solutions, catheter stabilization in a coronary cavity and blockade of fluid flow through coronary sinus was not mentioned. Objective solutions based on connection of multiple functionalities utilized by one catheter-electrode, give the operator new and useful possibilities.